Global Biotech Experts, LLC
Nadine Ritter has been a protein scientist for over 30 yrs. She received her BS in biology/chemistry from the University of Houston – Clear Lake in 1984, and her MA and PhD in cell and molecular biology from Rice University in 1988, followed by a four-year NIH postdoctoral project at the University of Texas – Houston in protein biochemistry. In 1992, she joined the biotech industry as a senior scientist at Abbott Laboratories. There, she engaged in the development, validation, tech transfer and troubleshooting of protein analytical methods for a wide variety of proteins and peptides. In 1998, she became director of analytical services at one of the first biotech CROs, BioReliance, where she managed contract R&D, GLP and cGMP laboratory operations and CMC analytical and stability studies for biotech products. In 2004, she became a senior CMC analytical consultant at Biologics Consulting Group, continuing to provide expert input to numerous product submissions and laboratory compliance operations around the world. In 2014, she launched Global Biotech Experts, a technical, regulatory and quality consultancy for product characterization, comparability, release and stability testing with expertise in standard and state-of-the-art physiochemical and functional methods of analysis. Since 1999, Nadine has been a highly popular public and internal trainer in CMC analytical science and laboratory compliance for biotech products. She currently serves as chair of the scientific advisory board and guest instructor for the University of Maryland Baltimore County Biotechnology Graduate Program. She is on the board of directors of several professional organizations and industry journals, and has numerous publications on biotechnology analytical methods and laboratory quality practices. Nadine is frequently invited around the world to speak and write on biotechnology product development and commercialization issues, and compliance requirements for testing laboratories.